EverCross™ AB35W06060135 (UDI 00763000184391)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000184391), received between Jul 3, 2019 and Oct 25, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EVERCROSS TO TREAT A PLAQUE LESION IN THE SUPERFICIAL FEMORAL ARTERY. EMBOLIC PROTECTION WAS NOT USED. IFU WAS FOLLOWED WITHOUT ISSUE. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. AN EVEREST WAS USED FOR DILATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. DEVICE WAS INFLATED WITH AN EVEREST. 50/50 CONTRAST WAS USED. IT IS REPORTED REMOVAL DIFFICULTIES OCCURRED, BUT THE DEVICE REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY OR INTERVENTION REQURIED. THE BALLOON CATHETER DID NOT CATCH UPON THE SHEATH DURING WITHDRAWAL. THERE WAS NO VESSEL DAMAGE. PROCEDURE COMPLETED WITH A NEW 6X60 EVERCROSS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531506 ↗
• MalfunctionMay 23, 2023Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON DURING TREATMENT OF A LESION IN THE PATIENT¿S DISTAL LEFT ARTERY/VEIN. MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. EMBOLIC PROTECTION WAS NOT USED. AN INFLATION DEVICE WAS USED FORBALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. A LONGITUDINAL BALLOON BURST DURING INFLATION IS REPORTED AT 10ATM. A SECOND EVERCROSS PTA BALLOON WAS ATTEMPTED TO BE USED BUT A LONGITUDINAL BALLOON BURST DURING INFLATION ALSO OCCURRED. THE BALLOONS DID NOT FRAGMENT AND NO INTERVENTION WAS REQUIRED TO REMOVE. THE DEVICES WERE SAFELY REMOVED FROM THE PATIENT. NO VESSEL INJURY NOTED. PROCEDURE WAS COMPLETED. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983241 ↗
• MalfunctionMar 31, 2023Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS USING AN EVERCROSS PTA BALLOON FOR THE TREATMENT OF A CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION. THE DEGREE OF CALCIFICATION WAS SEVERE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE BALLOON RUPTURED. ANOTHER BALLOON WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654782 ↗
• InjuryJul 21, 2022Obstruction of Flow; Difficult to Advance; Compatibility Problem; Obstruction of Flow; Difficult to Advance; Compatibility Problem

  DURING PROCEDURE A PHYSICIAN USED AN EVERCROSS PTA BALLOON FOR THE OPENING OF THE ILIAC ARTERY USING BALLOON DILATION AND STENT IMPLANTATION FOR ILIAC ARTERY STENOSIS. IT WAS REPORTED THAT THE INTERMEDIATE PATHWAY OF THE CATHETER COULD NOT PASS THROUGH THE GUIDE WIRE. DURING THE USE, IT WAS FOUND THAT THE PTA DILATION CATHETER COULD NOT PASS THE SUPPORT GUIDE WIRE. THE GUIDE WIRE USED DURING THE SURGERY WAS COOK'S 2.6 M 35 GUIDE WIRE. INFLUENCE OF THE PATIENT WAS REPORTED AS POSSIBLE DAMAGE TO BLOOD VESSELS AND TIME FOR TREATMENT. THE PROCEDURE WAS CONTINUED WITH THE REPLACEMENT OF THE PTA DILATION CATHETER. VASCULAR DAMAGE OCCURRED DUE TO EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15073208 ↗
• MalfunctionMay 16, 2022Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN USED AN EVERCROSS PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT A 40MM CALCIFIED LESION IN THE PATIENT'S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND COMMON FEMORAL ARTERY (CFA). ARTERY DIAMETER REPORTED AS 7MM. SEVERE VESSEL CALCIFICATION AND SLIGHT TORTUOSITY ARE REPORTED. LESION EXHIBITED 60-70% STENOSIS. AN INFLATION DEVICE WAS USED WITH A SALINE/CONTRAST MIX FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. A BALLOON BURST IS REPORTED. THE BALLOON HAD TROUBLE KEEPING PRESSURE WHOLE TIME. 1 PRIOR INFLATION HAD BEEN APPLIED TO THE DEVICE. THE BALLOON RUPTURED FAIRLY QUICKLY DURING INFLATION. IT IS BELIEVED THAT BALLOON RUPTURE WAS LARGE ENOUGH TO MAKE THE BALLOON DIFFICULT TO DEFLATE. PHYSICIAN USED MINIMAL FORCE TO ATTEMPT BALLOON REMOVAL WITHOUT SUCCESS. ADDITIONAL FORCE WAS APPLIED AND 6 FR 45 CM SHEATH AND BALLOON CATHETER WERE REMOVED TOGETHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14405729 ↗
• MalfunctionMay 19, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE AN EVERCROSS PTA BALLOON CATHETER DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE MID TO DISTAL IN THE SFA. A NON MEDTRONIC DEVICE INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. DEVICE WAS INSPECTED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT LONGITUDINAL BURST OCCURRED AND ALL BALLOON FRAGMENTS WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY IMPLANTED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, NO FORCE WAS USED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10069435 ↗
• MalfunctionJul 3, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING AN EVERCROSS PTA CATHETER WITH A TRAILBLAZER SUPPORT CATHETER TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE MID PROXIMAL COMMON ILIAC ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THEIR TRAY/HOOP. THE DEVICES WERE PREPPED PER IFU WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED. THE EVERCROSS WAS INFLATED TO 8ATM WITH A NON-MEDTRONIC INFLATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, BUT RESISTANCE WAS ENCOUNTERED BUT NO EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. THE EVERCROSS IS REPORTED TO HAVE BURST. THE 2 DEVICES WERE REMOVED TOGETHER AND THEN IT WAS NOTED THAT THE TRAILBLAZER DELIVERY CATHETER WAS DAMAGED. ALL FRAGMENTS OF THE BURST BALLOON WERE RETRIEVED. THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE AT A LATER DATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8758420 ↗